Pfizer Vfend approved
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryPfizer's antifungal Vfend (voriconazole) clears FDA May 24 for first-line treatment of invasive aspergillosis and "treatment of serious fungal infections caused by Scedosporium apiospermum and Fusarium spp, including Fusarium solani, in patients intolerant of, or refractory to, other therapy." Labeling contains bolded warnings on visual disturbances and hepatic toxicity. Vfend is available in 50 mg or 200 mg tablets and 200 mg I.V. vials. Pfizer submitted the NDAs in November 2000 and received an "approvable" letter Dec. 17, 200
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